The pharmaceutical industry continues to grapple with preclinical and clinical safety issues, with toxicity remaining a leading cause of drug failure. Cardiovascular toxicity, in particular, stands out, accounting for approximately 40% of all drug withdrawals due to safety concerns. To mitigate these risks, human induced pluripotent stem cell-derived cardiomyocytes (iPSC-CMs) have emerged as a critical tool for evaluating cardiac safety. Traditionally, most studies have relied on iPSC-CMs from one or two healthy donors, limiting the representation of broader population variability in drug response. [Read more…]
Lineage Takes Delivery of Genetically Engineered iPSC Line with Hypoimmunity Edits from Factor Bioscience
CARLSBAD, Calif. – Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing novel allogeneic, or “off the shelf,” cell therapies for serious medical conditions, announced the receipt of a novel, induced pluripotent stem cell (iPSC) line containing hypoimmunity edits, from Factor Bioscience Inc. (“Factor”). Generation of the line marks a successful milestone in the strategic collaboration between the two companies, under which Factor developed a proprietary, genetically engineered iPSC line that Lineage can utilize for differentiation into certain cell transplant product candidates. [Read more…]
Cellistic Launches Three New iPSC-based GMP Manufacturing Platforms to advance Immuno-Oncology and Regenerative Cell Therapies
Kobe University Introduces a Simplified Cryopreservation Method for iPSCs
Researchers at Kobe University have unveiled a novel cryopreservation technique that could meaningfully streamline how induced pluripotent stem cells (iPSCs) are stored and handled in laboratory settings. The newly reported method allows iPSCs to be frozen directly within standard culture dishes, eliminating the need for cell transfer prior to cryostorage, an advancement that may significantly improve workflow efficiency across stem cell research, drug discovery, and regenerative medicine. [Read more…]
GMP Manufacturing of iPSC Master Cell Banks for Allogeneic Therapies at REPROCELL:
A Cost-Optimized Approach
Are you advancing an iPSC therapy program and planning for clinical-scale manufacturing of GMP Master Cell Banks (MCBs)? REPROCELL provides industry-standard, GMP-compliant iPSC MCB manufacturing services that support robust regulatory pathways without compromising quality or operational discipline. Through our European partnership with Histocell and its EMA-authorized facility in Bilbao, Spain, together with REPROCELL’s U.S. GMP site in Beltsville, Maryland, we offer a dual-site manufacturing network aligned with FDA, EMA, and PMDA expectations.
This infrastructure provides the scale, regulatory alignment, and global flexibility needed for allogeneic therapy programs moving to clinical translation without the excessive costs often linked to iPSC GMP manufacturing. [Read more…]
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